Fezolinetant for the treatment of vasomotor symptoms associated with menopause: a meta-analysis

Abstract

This systematic review and meta-analysis investigated the efficacy and safety of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. PubMed, Cochrane Library, Embase and Web of Science were searched for randomized controlled trials (RCTs) published from inception to June 2023, comparing fezolinetant to placebo in postmenopausal women suffering from moderate-to-severe VMS. The mean difference and risk ratio were calculated for continuous and binary outcomes, respectively. R software was used for the statistical analysis, and RoB-2 (Cochrane) to assess the risk of bias. We performed subgroup analysis based on different dosing regimens. Five RCTs comprising 3302 patients were included. Compared with placebo, at 12-week follow-up, fezolinetant significantly reduced the daily frequency of moderate-to-severe VMS (weighted mean difference [WMD] − 2.36; 95% confidence interval [CI] − 2.92, −1.81) and daily severity of moderate-to-severe VMS (WMD −0.22; 95% CI −0.31, −0.13). Also, fezolinetant significantly improved the quality of life (WMD −0.42; 95% CI −0.58, −0.26) and sleep disturbance (WMD −1.10; 95% CI −1.96, −0.24). There were no significant differences between groups in adverse events. These findings support the efficacy and safety of fezolinetant for the treatment of VMS related to menopause.

摘要

这项系统性综述和荟萃分析研究了非唑奈坦治疗与绝经相关的中重度血管舒缩症状(VMS)的有效性和安全性。检索PubMed、Cochrane Library、Embase和Web of Science, 检索从建库至2023年6月发表的随机对照试验(RCT), 比较非唑奈坦和安慰剂在中重度VMS的绝经后女性中的作用。对于连续性变量和分类变量, 分别计算均数差和风险比。R软件用于统计分析, ROB-2(Cochrane)用于偏倚风险的评估。我们根据不同的给药方案进行亚组分析。纳入5项随机对照试验, 共3302名患者。与安慰剂相比, 在12周的随访中, 非唑奈坦显著降低了每日中重度VMS的频率(加权均数差SMD: −2.36；95%可信区间[CI]: −2.92, −1.81)和每日中重度VMS的严重程度(WMD: −0.22；95%CI: −0.31, −0.13)。此外, 非唑奈坦显著改善患者的生活质量(WMD: -0.42；95%CI: -0.58, −0.26)和睡眠障碍(WMD: −1.10；95%CI: −1.96, −0.24)。在不良事件方面, 两组之间没有显著差异。这些发现支持非唑奈坦治疗与绝经相关的VMS的有效性和安全性。

Keywords:

• Fezolinetant
• non-hormonal
• neurokinin 3 receptor antagonist
• menopause vasomotor symptoms
• sleep disorder

Disclosure statement

No potential conflict of interest was reported by the authors.

Funding

Nil.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.